Working adults experiencing poor sleep Mental and Behavioural Disorders
Conditions
Interventions
This study will incorporate two nested trials. The primary study will be a multi-arm, parallel-group, external pilot RCT with pre- and post-intervention assessments. Participants will be randomised to
ambient music and nature sounds, each of which is 30-60 minutes in duration), and
2. Sleep Tales (ST
narrated stories, typically 15-40 minutes in duration, that include background music and/or sound cues).
Both categories are designed to be used prior to or immediately before bed, as an aid to fallin
Sponsors
Unmind Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Being at least 18 years old 2. Currently residing in the UK 3. Self-identifying as being in full- or part-time employment 4. Self-reporting probable experience of poor sleep, defined as scoring =7 on the Jenkins Sleep Scale (JSS) 5. Self-reporting an interest in improved sleep 6. Being fluent in English 7. Having access to the Internet at home via a smartphone, laptop, desktop computer, or tablet 8. Owning a smartphone (and/or tablet. and being willing to download and sign up to the Unmind app 9. Willing to be randomised 10. Having an active account on the Prolific online recruitment platform (https://www.prolific.co).
Exclusion criteria
Exclusion criteria: 1. Undergoing treatment for a sleep disorder with a health professional 2. Previous use of the Unmind platform 3. Current participation in a separate study involving use of the Unmind app
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes will be captured through a combination of objective adherence data (captured continuously via the Unmind app. and a feedback questionnaire delivered post-intervention (4 weeks after baseline), and will be reported for each intervention arm separately (unless otherwise indicated). Outcomes will be equivalent for both the primary and secondary studies, and will include: 1. Feasibility: Recruitment, intervention uptake, and retention at post-intervention. 2. Acceptability: Intervention adherence (the proportion of participants completing, on average, at least 3 Sleep Tools per week, or 12 in total, where a playtime =5 minutes will be considered sufficient for completion), participant satisfaction, reasons for failing to adhere to the intervention, and qualitative feedback. 3. Engagement: Average number of Sleep Tools used (for NW and ST, and combined across both), the average duration (in minutes. Sleep Tools are played (accounting for Tools that are stopped early), self-reported conditions that prompt Sleep Tool usage, self-reported patterns of Sleep Tool usage (e.g. frequency of use before bed versus after waking in the night), and one question adapted from Section B of the Mobile App Rating Scale (MARS). 4. Transferability: One item adapted from Section E of the MARS. 5. Relevance: One item assessing subjective relevance of the Sleep Tools 6. Negative effects: The proportion of participants whose mental health (as measured by the Patient Health Questionnaire-4 [PHQ-4]. and sleep quality (as measured by the PROMIS Sleep Disturbance Short Form [SD-SF]. reliably deteriorates from baseline to post-intervention (based on a calculation of reliable change index for each measure. in NW and ST relative to the wait-list group; one item capturing lasting bad effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following standardised, self-report measures will be completed at baseline (t0. and post-intervention (t1, 4 weeks after t0. for the primary trial, and post-intervention (4 weeks after t1. for the secondary trial (with the exception of the Single Item Sleep Quality Scale [SQS], which will be completed at screening instead of t0): 1. PROMIS Sleep Disturbance Short Form 8a (SD-SF) 2. PROMIS Sleep Related Impairment Short Form 8a (SRI-SF) 3. Single Item Sleep Quality Scale (SQS) 4. Work Productivity and Activity Impairment (WPAI) 5. Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) 6. Unmind Index (Overall Score only) 7. Patient Health Questionnaire-4 (PHQ-4) | — |
Countries
England, United Kingdom
Contacts
Public ContactMarcos Economides
Outcome results
None listed